JP6006610B2 - Bioabsorbable tissue reinforcement - Google Patents
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本発明は、取扱い性に優れ、生体組織の細かな凹凸にも充分に追随することができ、かつ、最小限のフィブリン糊との併用でも充分に体液漏れ、空気漏れを防止することができる生体吸収性組織補強材に関する。 The present invention is excellent in handleability, can sufficiently follow fine irregularities of living tissue, and can sufficiently prevent body fluid leakage and air leakage even in combination with the minimum fibrin glue. The present invention relates to an absorbent tissue reinforcing material.
外科手術により生体組織の一部を切除したときに、切除面からの術後出血や胆汁等の体液の漏れは術後合併症の原因になる。また、肺等の組織を切除した場合には、切除面からの空気漏れを防止する必要がある。 When a part of living tissue is excised by surgery, postoperative bleeding from the excised surface and leakage of bodily fluids such as bile cause postoperative complications. Further, when a tissue such as the lung is excised, it is necessary to prevent air leakage from the excised surface.
このような体液漏れ、空気漏れを防止する方法として、フィブリノーゲンとトロンビン液とを含有するフィブリン糊を塗布又はスプレーして、切除面を被覆する方法が行われている。ここで、フィブリン糊単体の使用では充分な被覆効果が得られないことから、現在では、不織布からなる組織補強材とフィブリン糊とを併用することが一般的である。外科手術による生体組織の切除面の補強として、組織補強材とフィブリン糊との併用は、体液漏れ、空気漏れを有効に防止できると認められている。 As a method for preventing such body fluid leakage and air leakage, a method of coating or spraying fibrin glue containing fibrinogen and thrombin solution to coat the excised surface is performed. Here, since a sufficient covering effect cannot be obtained by using a single fibrin glue, it is now common to use a tissue reinforcing material made of a nonwoven fabric and a fibrin glue in combination. It has been recognized that combined use of tissue reinforcing material and fibrin glue can effectively prevent body fluid leakage and air leakage as reinforcement of the excised surface of living tissue by surgery.
組織補強材は、適度な空隙を持つため、フィブリン糊を切除面に固定するための支持材として適している。なかでも、特許文献１に開示されているような生体吸収性の不織布からなる組織補強材を用いれば、生体内で分解、吸収されることから、慢性期の異物反応が発生することがなく、組織補強材を取り出すための再手術の必要もない。 Since the tissue reinforcing material has an appropriate gap, it is suitable as a support material for fixing the fibrin glue to the cut surface. Among them, if a tissue reinforcing material made of a bioabsorbable nonwoven fabric as disclosed in Patent Document 1 is used, it is decomposed and absorbed in the living body, so that a foreign body reaction in the chronic phase does not occur. There is no need for re-operation to remove the tissue reinforcement.
しかしながら、外科手術の切除面は均一とはいえず、細かな凹凸が存在する。従来の市販の生体吸収性の不織布からなる組織補強材では、このような生体組織の細かな凹凸に充分に追随できず、切除面を被覆した場合に隙間が発生するという問題があった。フィブリン糊を含浸した組織補強材は一体化したフィルム状となっているため、この隙間は一種の閉鎖された空間となる。切除した組織が胃、肝臓、膵臓等の場合、切除面から漏出した消化液や膵液が閉鎖された空間内に貯留してしまい、炎症を引き起こす原因となってしまう。 However, the surgical resection surface is not uniform, and there are fine irregularities. A conventional tissue reinforcing material made of a commercially available bioabsorbable non-woven fabric cannot sufficiently follow such fine irregularities of the living tissue, and has a problem that a gap is generated when the cut surface is covered. Since the tissue reinforcing material impregnated with fibrin glue is an integrated film, this gap becomes a kind of closed space. When the excised tissue is the stomach, liver, pancreas, etc., the digestive juice or pancreatic juice leaking from the excision surface is stored in a closed space, causing inflammation.
また、フィブリン糊は生体由来の血液製剤であるため、カルテの長期保管やインフォームド・コンセント等の特別な管理が必要である。また、将来の潜在的リスクが完全に否定されているわけでもない。従って、極力使用量を減らすことも要望されていた。 In addition, since fibrin glue is a blood product derived from living organisms, special management such as long-term storage of medical records and informed consent is required. Nor is future potential risk completely denied. Therefore, it has been desired to reduce the amount of use as much as possible.
本発明は、取扱い性に優れ、生体組織の細かな凹凸にも充分に追随することができ、かつ、最小限のフィブリン糊との併用でも充分に体液漏れ、空気漏れを防止することができる生体吸収性組織補強材を提供することを目的とする。 The present invention is excellent in handleability, can sufficiently follow fine irregularities of living tissue, and can sufficiently prevent body fluid leakage and air leakage even in combination with the minimum fibrin glue. An object is to provide an absorbent tissue reinforcement.
本発明は、平均繊維径が０．９〜７．０μｍの生体吸収性材料からなる不織布からなる生体吸収性組織補強材である。
以下に本発明を詳述する。
The present invention is a bioabsorbable tissue reinforcing material comprising a nonwoven fabric made of a bioabsorbable material having an average fiber diameter of 0.9 to 7.0 μm.
The present invention is described in detail below.
本発明者は、従来の市販の生体吸収性の不織布からなる組織補強材が生体組織の細かな凹凸に充分に追随できない原因について検討した。その結果、従来の組織補強材では、硬く、腰が強すぎるために凹凸に追従できないことを見出した。組織補強材を柔軟化する方法としては、例えば、面密度を下げることが考えられる。しかしながら、面密度を下げて柔軟化すると、取扱い性に劣るうえ、相対的な強力が低下するので充分な補強効果が得られなくなるという問題があった。 The present inventor examined the reason why a tissue reinforcing material made of a conventional commercially available bioabsorbable nonwoven fabric cannot sufficiently follow the fine irregularities of the living tissue. As a result, it has been found that the conventional tissue reinforcing material cannot follow the unevenness because it is hard and too stiff. As a method for softening the tissue reinforcing material, for example, it is conceivable to reduce the surface density. However, when the surface density is lowered and softened, there is a problem in that the handleability is inferior and the relative strength is lowered, so that a sufficient reinforcing effect cannot be obtained.
本発明者は、更に鋭意検討した結果、生体吸収性の不織布を構成する繊維の平均繊維径を０．９〜７．０μｍの範囲とすることにより、生体組織の細かな凹凸への追従性と、取扱い性とを両立できることを見出し、本発明を完成した。
即ち、平均繊維径が０．９〜７．０μｍの生体吸収性材料からなる不織布は、乾燥状態においては充分な硬さや腰を有することから、手術現場において容易にトリミングを行うことができ、取扱い性に優れる。一方、生体内のような水分が多い環境下に置くと、驚くべきことに素材自体は疎水性であるにもかかわらず、構造体内に水分を取り込んで柔軟化し、生体組織の細かな凹凸へも充分に追従できるようになる。このように組織補強材自体の生体組織の切除面に対する密着性が向上することにより、より少ない量のフィブリン糊でも充分に体液漏れ、空気漏れを防止できることから、フィブリン糊の使用量の低減をも達成することができる。更に、水分を取り込んで柔軟化しても充分な強度を有することから、補強効果も発揮できる。
As a result of further intensive studies, the present inventor made the average fiber diameter of the fibers constituting the bioabsorbable nonwoven fabric in the range of 0.9 to 7.0 μm, thereby allowing followability to fine irregularities of the living tissue. The present invention has been completed by finding that it is possible to achieve both handleability.
That is, a nonwoven fabric made of a bioabsorbable material having an average fiber diameter of 0.9 to 7.0 μm has sufficient hardness and waist in a dry state, so that it can be easily trimmed at the operation site and handled. Excellent in properties. On the other hand, when placed in an environment with a lot of moisture, such as in the living body, surprisingly, the material itself is hydrophobic, but it takes water into the structure and softens it. It will be able to follow up sufficiently. Thus, by improving the adhesion of the tissue reinforcing material itself to the excision surface of the living tissue, even a smaller amount of fibrin glue can sufficiently prevent body fluid leakage and air leakage, thus reducing the amount of fibrin glue used. Can be achieved. Furthermore, even if it takes in moisture and it softens, since it has sufficient intensity | strength, the reinforcement effect can also be exhibited.
本発明の生体吸収性組織補強材は、平均繊維径が０．９〜７．０μｍの生体吸収性材料からなる不織布（以下、単に「不織布」ともいう。）からなる。
上記生体吸収性材料は特に限定されず、例えば、ポリグリコリド、ポリラクチド（Ｄ、Ｌ、ＤＬ体）、ポリカプロラクトン、グリコール酸−ラクチド（Ｄ、Ｌ、ＤＬ体）共重合体、グリコール酸−ε−カプロラクトン共重合体、ラクチド（Ｄ、Ｌ、ＤＬ体）−ε−カプロラクトン共重合体、ポリ（ｐ−ジオキサノン）等が挙げられる。これらは単独で用いられてもよく、２種以上を併用してもよい。なかでも、ポリグリコリド又はラクチド（Ｄ、Ｌ、ＤＬ体）−ε−カプロラクトン共重合体が好ましく、ポリグリコリドがより好ましい。
The bioabsorbable tissue reinforcing material of the present invention is composed of a nonwoven fabric (hereinafter also simply referred to as “nonwoven fabric”) made of a bioabsorbable material having an average fiber diameter of 0.9 to 7.0 μm.
The bioabsorbable material is not particularly limited. For example, polyglycolide, polylactide (D, L, DL form), polycaprolactone, glycolic acid-lactide (D, L, DL form) copolymer, glycolic acid-ε- Examples include caprolactone copolymer, lactide (D, L, DL form) -ε-caprolactone copolymer, poly (p-dioxanone) and the like. These may be used independently and may use 2 or more types together. Among these, polyglycolide or lactide (D, L, DL form) -ε-caprolactone copolymer is preferable, and polyglycolide is more preferable.
上記生体吸収性材料の分子量は特に限定されないが、例えばポリグリコリドの場合には、重量平均分子量の好ましい下限が３００００、好ましい上限が２０００００である。上記ポリグリコリドの重量平均分子量が３００００未満であると、強度が不足して充分な組織補強効果が得られないことがあり、２０００００を超えると、生体内における分解速度が遅くなり、異物反応を起こすことがある。上記ポリグリコリドの重量平均分子量のより好ましい下限は５００００、より好ましい上限は１５００００である。 Although the molecular weight of the said bioabsorbable material is not specifically limited, For example, in the case of polyglycolide, the preferable minimum of a weight average molecular weight is 30000, and a preferable upper limit is 200000. If the weight average molecular weight of the polyglycolide is less than 30000, the strength may be insufficient and a sufficient tissue reinforcing effect may not be obtained. If the weight average molecular weight exceeds 200000, the degradation rate in the living body is slowed down, causing a foreign body reaction. Sometimes. The minimum with a more preferable weight average molecular weight of the said polyglycolide is 50000, and a more preferable upper limit is 150,000.
上記不織布は、平均繊維径の下限が０．９μｍ、上限が７．０μｍである。上記不織布の平均繊維径がこの範囲にある場合に、生体組織の細かな凹凸への追従性と、取扱い性、補強効果とを両立することができる。上記不織布の平均繊維径が０．９μｍ未満であると、取扱い性が低下し、手術現場においてトリミング等を行うことが困難となり、切除面を被覆したときに充分な補強効果を発揮できないことがある。上記不織布の平均繊維径が７．０μｍを超えると、生体組織の細かな凹凸への追従性が低下してしまう。上記不織布の平均繊維径の好ましい上限は３．０μｍである。なかでも、平均繊維径が１．５〜２．０μｍである場合に特に優れた効果が発揮される。
なお、本明細書において不織布の平均繊維径は、生地の中央の一部を切り取り、電子顕微鏡を用いて観察して繊維径をランダムに１０カ所測定し、平均したものを意味する。
The lower limit of the average fiber diameter of the nonwoven fabric is 0.9 μm, and the upper limit is 7.0 μm. When the average fiber diameter of the nonwoven fabric is within this range, it is possible to achieve both followability to fine irregularities of the living tissue, handleability, and reinforcing effect. When the average fiber diameter of the non-woven fabric is less than 0.9 μm, the handleability is lowered, and it is difficult to perform trimming or the like at the operation site, and when the cut surface is covered, a sufficient reinforcing effect may not be exhibited. . When the average fiber diameter of the nonwoven fabric exceeds 7.0 μm, the followability to fine irregularities of the living tissue is deteriorated. The upper limit with a preferable average fiber diameter of the said nonwoven fabric is 3.0 micrometers. Among these, particularly excellent effects are exhibited when the average fiber diameter is 1.5 to 2.0 μm.
In the present specification, the average fiber diameter of the nonwoven fabric means an average fiber diameter obtained by cutting a part of the center of the fabric, observing it with an electron microscope, measuring 10 fiber diameters at random.
上記不織布は、面密度の好ましい下限が３ｇ／ｍ２、好ましい上限が２０ｇ／ｍ２である。面密度が３ｇ／ｍ２未満であると、組織補強効果が充分に得られないことがあり、２０ｇ／ｍ２を超えると、生体組織への接着性が低下してしまうことがある。上記不織布の面密度のより好ましい下限は５ｇ／ｍ２、より好ましい上限は１５ｇ／ｍ２である。 The above-mentioned nonwoven fabric has a preferable lower limit of the surface density of 3 g / m 2 and a preferable upper limit of 20 g / m 2 . When the surface density is less than 3 g / m 2 , the tissue reinforcing effect may not be sufficiently obtained, and when it exceeds 20 g / m 2 , the adhesiveness to the living tissue may be deteriorated. The more preferable lower limit of the surface density of the nonwoven fabric is 5 g / m 2 , and the more preferable upper limit is 15 g / m 2 .
上記不織布の厚さは特に限定されないが、好ましい下限は０．０１μｍ、好ましい上限は０．２μｍである。厚さが０．０１μｍ未満であると、強度が不足して脆弱な組織の補強には用いることができないことがあり、０．２μｍを超えると、生体組織の細かな凹凸への追従性が低下してしまうことがある。厚さのより好ましい下限は０．０３μｍ、より好ましい上限は０．１μｍである。 Although the thickness of the said nonwoven fabric is not specifically limited, A preferable minimum is 0.01 micrometer and a preferable upper limit is 0.2 micrometer. If the thickness is less than 0.01 μm, it may not be used to reinforce a weak tissue due to insufficient strength, and if it exceeds 0.2 μm, the followability to fine irregularities of the living tissue is reduced. May end up. A more preferable lower limit of the thickness is 0.03 μm, and a more preferable upper limit is 0.1 μm.
上記不織布を製造する方法は特に限定されず、例えば、エレクトロスピニングデポジション法、メルトブロー法、ニードルパンチ法、スパンボンド法、フラッシュ紡糸法、水流交絡法、エアレイド法、サーマルボンド法、レジンボンド法、湿式法等の従来公知の方法を用いることができる。なかでも、原材料となる生体吸収性材料を溶媒で溶解させる必要がないメルトブロー法が好適である。 The method for producing the non-woven fabric is not particularly limited. A conventionally known method such as a wet method can be used. Among these, a melt blow method that does not require a bioabsorbable material as a raw material to be dissolved with a solvent is preferable.
本発明の生体吸収性組織補強材は、上記不織布からなることにより、乾燥状態においては充分な硬さや腰を有し、手術現場において容易にトリミングを行うことができる。一方、生体内のような水分が多い環境下に置くと、構造体内に水分を取り込んで柔軟化し、生体組織の細かな凹凸へも充分に追従できるようになる。このように生体組織の細かな凹凸にも充分に追随することができることにより、外科手術により生体組織の一部を切除したときの切除面に貼付することにより、体液漏れや空気漏れを防止することができる。
本発明の生体吸収性組織補強材は、ＪＩＳ Ｌ１０６９に準ずるカンチレバーによる剛軟度測定において、水を含浸させたときの軟化率が４０％以上である。
本発明の生体吸収性組織補強材は、水を含浸させた状態で、ＪＩＳ Ｚ０２３７に準ずる方法により測定したステンレス板に対する接着力が０．０５３Ｎ／ｍ以上である。
本発明の生体吸収性組織補強材は、ＪＩＳ Ｌ１９１２（医療用不織布試験方法）の７．１耐水度試験（静水圧法）７．１．１Ａ法（低水圧法）に準じて耐水性試験を行ったときの耐水性が７．４±１．８ｍｍＨ２Ｏ以上である。
Since the bioabsorbable tissue reinforcing material of the present invention is made of the above-mentioned nonwoven fabric, it has sufficient hardness and waist in a dry state, and can be easily trimmed at the operation site. On the other hand, when placed in an environment where there is a lot of moisture such as in a living body, moisture is taken into the structure to be softened, and the fine irregularities of the living tissue can be sufficiently followed. By being able to sufficiently follow the fine irregularities of the living tissue in this way, it is possible to prevent body fluid leakage and air leakage by applying it to the excision surface when part of the living tissue is excised by surgery. Can do.
The bioabsorbable tissue reinforcing material of the present invention has a softening ratio of 40% or more when impregnated with water in a bending resistance measurement using a cantilever according to JIS L1069.
The bioabsorbable tissue reinforcing material of the present invention has an adhesive strength of 0.053 N / m or more measured with a method according to JIS Z0237 in a state of being impregnated with water.
The bioabsorbable tissue reinforcing material of the present invention is subjected to a water resistance test in accordance with 7.1 water resistance test (hydrostatic pressure method) 7.1.1A method (low water pressure method) of JIS L1912 (medical nonwoven fabric test method). Water resistance when performed is 7.4 ± 1.8 mmH 2 O or more.
本発明の生体吸収性組織補強材は、外科手術により生体組織の一部を切除したときの切除面に貼付することにより、体液漏れや空気漏れを防止することができる。貼付時には、フィブリン糊を併用することが好ましいが、本発明の生体吸収性組織補強材自体の切除面への接着性が優れることから、従来に比べて少ないフィブリン糊の使用量でも充分な効果を得ることができる。また、症例によっては、フィブリン糊を併用せずに本発明の生体吸収性組織補強材単体でも充分な効果を得ることができる。 The bioabsorbable tissue reinforcing material of the present invention can prevent body fluid leakage and air leakage by sticking to a resection surface when a part of the biological tissue is excised by surgery. At the time of application, it is preferable to use a fibrin glue in combination. Can be obtained. In some cases, a sufficient effect can be obtained with the bioabsorbable tissue reinforcing material alone of the present invention without using fibrin glue.
本発明によれば、取扱い性に優れ、生体組織の細かな凹凸にも充分に追随することができ、かつ、最小限のフィブリン糊との併用でも充分に体液漏れ、空気漏れを防止することができる生体吸収性組織補強材を提供することができる。 According to the present invention, it is excellent in handleability, can sufficiently follow fine irregularities of living tissue, and can sufficiently prevent body fluid leakage and air leakage even in combination with the minimum fibrin glue. A bioabsorbable tissue reinforcing material that can be provided can be provided.
以下に実施例を挙げて本発明の態様を更に詳しく説明するが、本発明はこれら実施例にのみ限定されるものではない。 Hereinafter, embodiments of the present invention will be described in more detail with reference to examples. However, the present invention is not limited to these examples.
（実施例１、２）
生体吸収性材料としてポリグリコリドを用い、スクリュー径２０ｍｍの汎用小型押出機にてメルトブロー法により不織布を作製した。ホッパー内を窒素ガスパージし、熱風下にて紡糸を行い、吐出量とベルトコンベアの速度を調整することにより不織布を得た。
得られた不織布を走査型電子顕微鏡（ＳＥＭ）により倍率５０倍、１００倍及び１０００倍にて観察した。各倍率でのＳＥＭ像を図１、２に示した。図１、２より、実施例１で得られた不織布の繊維径範囲は０．９〜１７μｍ、平均繊維径は１．５μｍであり、実施例２で得られた不織布の繊維径範囲は０．９〜１７μｍ、平均繊維径は２．０μｍであった。
(Examples 1 and 2)
Polyglycolide was used as a bioabsorbable material, and a nonwoven fabric was produced by a melt blow method using a general-purpose small extruder having a screw diameter of 20 mm. The inside of the hopper was purged with nitrogen gas, spinning was performed under hot air, and the discharge amount and the speed of the belt conveyor were adjusted to obtain a nonwoven fabric.
The obtained nonwoven fabric was observed with a scanning electron microscope (SEM) at a magnification of 50 times, 100 times, and 1000 times. SEM images at each magnification are shown in FIGS. 1 and 2, the fiber diameter range of the nonwoven fabric obtained in Example 1 is 0.9 to 17 μm, the average fiber diameter is 1.5 μm, and the fiber diameter range of the nonwoven fabric obtained in Example 2 is 0.00. The average fiber diameter was 9 to 17 μm and 2.0 μm.
実施例１、２で得られた不織布を１０ｃｍ×１０ｃｍの大きさにトリミングし、重量を測定する方法により面密度を求めた。
実施例１で得られた不織布の面密度は５ｇ／ｍ２、実施例２で得られた不織布の面密度は１０ｇ／ｍ２であった。
The nonwoven fabrics obtained in Examples 1 and 2 were trimmed to a size of 10 cm × 10 cm, and the surface density was determined by a method of measuring the weight.
The surface density of the nonwoven fabric obtained in Example 1 was 5 g / m 2 , and the surface density of the nonwoven fabric obtained in Example 2 was 10 g / m 2 .
（比較例１）
比較例として、市販のポリグリコリドからなる不織布（グンゼ社製、ネオベールＮＶ−Ｌ−０１５Ｇ）を準備した。
該不織布を走査型電子顕微鏡（ＳＥＭ）により倍率５０倍、１００倍及び１０００倍にて観察した。各倍率でのＳＥＭ像を図３に示した。図３より、比較例１の不織布の繊維径範囲は１５〜２５μｍ、平均繊維径は２０μｍであった。
また、比較例１の不織布を１０ｃｍ×１０ｃｍの大きさにトリミングし、重量を測定する方法により面密度を求めたところ、３５ｇ／ｍ２であった。
(Comparative Example 1)
As a comparative example, a non-woven fabric made of a commercially available polyglycolide (Gunze, Neobale NV-L-015G) was prepared.
The nonwoven fabric was observed with a scanning electron microscope (SEM) at magnifications of 50 times, 100 times, and 1000 times. SEM images at various magnifications are shown in FIG. From FIG. 3, the fiber diameter range of the nonwoven fabric of Comparative Example 1 was 15 to 25 μm, and the average fiber diameter was 20 μm.
Moreover, when the nonwoven fabric of the comparative example 1 was trimmed to the magnitude | size of 10 cm x 10 cm and the surface density was calculated | required by the method of measuring a weight, it was 35 g / m < 2 >.
（評価）
実施例及び比較例の不織布からなる生体吸収性組織補強材について、以下の方法により評価を行った。
結果を表１に示した。
(Evaluation)
The bioabsorbable tissue reinforcing materials composed of the nonwoven fabrics of Examples and Comparative Examples were evaluated by the following methods.
The results are shown in Table 1.
（１）軟化率の評価
ＪＩＳ Ｌ１０９６に準ずるカンチレバーによる剛軟度測定において、実施例及び比較例の不織布からなる生体吸収性組織補強材に水を含浸させたときの軟化率を測定した。
即ち、各不織布を２ｃｍ×１２ｃｍに切断してサンプルとした。乾燥状態のサンプルを、図４に示した先端が４５°の斜面を有する台上に基線にあわせて置いた（図４（ａ））。次いで、サンプルを斜面の方向に押出し、サンプルの先端が斜面と接したときの他端の位置を読み、押し出された距離を測定した（図４（ｂ））。同様の試験を、サンプルに蒸留水を含浸させた状態で行い、押し出された距離を測定した。
得られた結果から、下記式により軟化率を算出した。
軟化率＝｛（乾燥状態における押し出された距離）−（水を含浸させた状態での押し出された距離）｝／（乾燥状態における押し出された距離）×１００
なお、各測定は各々ｎ＝３のサンプルで、各サンプルについて上下、裏表の４方向で行い、その平均値を「押し出された距離」とした。
(1) Evaluation of softening rate In the bending resistance measurement by the cantilever according to JIS L1096, the softening rate when the bioabsorbable tissue reinforcing material made of the nonwoven fabric of Examples and Comparative Examples was impregnated with water was measured.
That is, each nonwoven fabric was cut into 2 cm × 12 cm to obtain samples. The sample in a dry state was placed on a table having a slope with a 45 ° tip as shown in FIG. 4 along the base line (FIG. 4A). Next, the sample was extruded in the direction of the slope, the position of the other end when the tip of the sample contacted the slope was read, and the extruded distance was measured (FIG. 4B). A similar test was performed in a state where the sample was impregnated with distilled water, and the extruded distance was measured.
From the obtained results, the softening rate was calculated by the following formula.
Softening rate = {(extruded distance in a dry state) − (extruded distance in a state impregnated with water)} / (extruded distance in a dry state) × 100
Each measurement was performed with n = 3 samples, and each sample was measured in four directions, up and down, and front and back, and the average value was defined as “extruded distance”.
（２）接着性の評価
不織布に水を含浸させた状態で、ＪＩＳ Ｚ０２３７に準ずる方法により測定したステンレス板に対する接着力を測定した。
即ち、各不織布を１６ｃｍ×３５ｃｍに切断してサンプルとした。サンプルに蒸留水を含浸させた状態でステンレス板に貼り付けた。この状態から、図５に示したようにサンプルを１８０°方向に引っ張ってステンレス板から剥離するのに必要な力を測定して、接着力を算出した。
(2) Adhesive evaluation The adhesive strength with respect to the stainless steel plate measured by the method according to JIS Z0237 was measured in the state which impregnated the nonwoven fabric with water.
That is, each nonwoven fabric was cut into 16 cm × 35 cm to obtain samples. The sample was affixed to a stainless steel plate while impregnated with distilled water. From this state, the force required to peel the sample from the stainless steel plate by pulling it in the 180 ° direction as shown in FIG. 5 was measured, and the adhesive force was calculated.
（３）耐水性の評価
ＪＩＳ Ｌ１９１２（医療用不織布試験方法）の７．１耐水度試験（静水圧法）７．１．１Ａ法（低水圧法）に準じて耐水性試験を行った。
即ち、各不織布を５．０ｃｍ×５．０ｃｍに切断してサンプルとした。図６に示したように、サンプルが耐える水柱高さの最大値を測定して、耐水性とした。
(3) Evaluation of water resistance A water resistance test was conducted according to 7.1 water resistance test (hydrostatic pressure method) 7.1.1A method (low water pressure method) of JIS L1912 (medical nonwoven fabric test method).
That is, each nonwoven fabric was cut into 5.0 cm × 5.0 cm to obtain samples. As shown in FIG. 6, the maximum value of the water column height that the sample can withstand was measured to make it water resistant.
本発明によれば、取扱い性に優れ、生体組織の細かな凹凸にも充分に追随することができ、かつ、最小限のフィブリン糊との併用でも充分に体液漏れ、空気漏れを防止することができる生体吸収性組織補強材を提供することができる。 According to the present invention, it is excellent in handleability, can sufficiently follow fine irregularities of living tissue, and can sufficiently prevent body fluid leakage and air leakage even in combination with the minimum fibrin glue. A bioabsorbable tissue reinforcing material that can be provided can be provided.
Claims (1)
面密度が３〜２０ｇ／ｍ ２ であり、
ＪＩＳ Ｌ１０６９に準ずるカンチレバーによる剛軟度測定において、水を含浸させたときの軟化率が４０％以上であり、
水を含浸させた状態で、ＪＩＳ Ｚ０２３７に準ずる方法により測定したステンレス板に対する接着力が０．０５３Ｎ／ｍ以上であり、
ＪＩＳ Ｌ１９１２（医療用不織布試験方法）の７．１耐水度試験（静水圧法）７．１．１Ａ法（低水圧法）に準じて耐水性試験を行ったときの耐水性が７．４±１．８ｍｍＨ ２ Ｏ以上である
ことを特徴とする生体吸収性組織補強材。
A bioabsorbable tissue reinforcing material comprising a nonwoven fabric made of a bioabsorbable material having an average fiber diameter of 0.9 to 7.0 μm ,
The surface density is 3 to 20 g / m 2 ;
In the bending resistance measurement by a cantilever according to JIS L1069, the softening rate when impregnated with water is 40% or more,
In a state impregnated with water, the adhesive strength to the stainless steel plate measured by a method according to JIS Z0237 is 0.053 N / m or more,
The water resistance when the water resistance test is carried out according to 7.1 water resistance test (hydrostatic pressure method) 7.1.1A method (low water pressure method) of JIS L1912 (medical nonwoven fabric test method) is 7.4 ±. bioabsorbable tissue reinforcement, wherein <br/> that 1.8mmH at 2 O or more.
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